FDA Issues Safety Alert for SCC and Various Lymphomas in Scar Tissue around Breast Implants

The U.S. Food and Drug Administration (FDA) is informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. 

“After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare,” says  Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the FDA's Center for Devices and Radiological Health.”However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.”

In some reported cases, patients were diagnosed years after having breast implants and presented with findings such as swelling, pain, lumps,  or skin changes. These emerging reports of lymphoma in scar tissue are different from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA began communicating about as a potential risk more than a decade ago.  

The FDA continues to engage top cancer experts and are consulting with our Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field. Additionally, the agency continues to closely monitor various data sources, such as the scientific literature, adverse event reports submitted to the agency and is soliciting information from manufacturers regarding any reports they may have regarding SCC and other lymphomas related to the tissue around an implant.

“We know that breast implants are not lifetime devices, and that the longer a patient has breast implants, the more likely they will need to be removed or replaced,” Ashar says. “We also understand that information regarding breast implant risks can be overwhelming for a patient.”

The FDA website offers  easy-to-understand information in the patient brochure.

The bottom line?

Right now, there’s not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others.  For this reason, instances of SCC, lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA.

“Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed,” Ashar says. “As the agency moves further into adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is crucial.”

If a patient with breast implants is experiencing a problem, or there is a case of SCC, lymphoma or any other cancer of the breast implant capsule identified, the FDA strongly encourages reporting this through MedWatch, the FDA Safety Information and Adverse Event Reporting program. 

Lab test could monitor breast implant safety

In related news, a pair of UCLA scientists are developing a lab test aimed at detecting silicone implant ruptures which they think may also help explain why many women who received implants have later reported a constellation of systemic symptoms.

The Food and Drug Administration recently elevated safety warnings over breast implants after collecting reports from hundreds of thousands of women about a novel cancer and other chronic conditions, like brain fog, joint pain and fatigue. The range of symptoms is often called “breast implant illness” and the silicone used in implants is seen as a possible culprit.

Kym Faull, a professor of psychiatry and biobehavioral sciences at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, and Dr. Michael DeLong, an assistant professor-in-residence in plastic and reconstructive surgery at UCLA Health, have been working on a test that can measure silicone metabolites in patient blood and urine samples.

“There was some preliminary evidence in the medical literature that some of these little silicone molecules in implants may be leaching out,” says Dr. DeLong, who was recently appointed to a Food and Drug Administration advisory panel on general and plastic surgery devices, in a UCLA blog post. “We thought maybe our test can detect these, and it would be a better way of identifying rupture.”

While rupture rates are thought to be low, the risk increases as the implants age and most ruptures in silicone implants are thought to be “silent,” or asymptomatic.

The only way to confirm an implant rupture or leak is through surgery to visualize the implant, although MRI studies are non-invasive and can be relatively accurate. While the FDA recommends regular screenings for patients with silicone implants, historically very few patients have followed this recommendation.

The FDA convened a special advisory committee to examine breast implant safety in Spring 2019. Last fall, the agency added a “black box” warning on breast implants and required that patients be informed that breast implants have been linked to an immune system cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and that many women with breast implants have reported otherwise unexplained symptoms.

This work, being conducted at the Semel Institute’s Pasarow Mass Spectrometry Laboratory overseen by Faull, could potentially be applied clinically for identifying breast implant ruptures and help provide answers about breast implant safety.

The UCLA scientists said they believe their test is one of very few – if not the only – research efforts aimed at identifying breast implant leaks without the use of imaging technology. They continue to refine the test but said they believe they were able to identify silicone molecules in an earlier version.

Faull and Dr. DeLong have also been working with a local plastic surgeon in Beverly Hills, Dr. Kevin Brenner, to study patients experiencing symptoms related to breast implant illness, and they are hoping to recruit more patients. 

The FDA will soon complete a thorough literature review and continueto work with the American Society of Plastic Surgeons to identify ways to collect more detailed information regarding patient cases where cancer in the breast implant capsule has been reported.